510(k) K101835
K101835 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079". The FDA issued a decision of Substantially Equivalent on Dec 3, 2010. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Porex Surgical, Inc. has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 3, 2010
- Date Received
- Jul 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Plate, Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5360
- Review Panel
- NE
- Submission Type
- 510(k)